Presale! Environmental Monitoring: A Comprehensive Handbook Volume 9
- Published
- Jun 2025
- ISBN
- 978-1-917195-18-8
- Pages
- 450
- PDA Item Number
- 43576
- Format
- PDF Single User
- Member Price
- $269.00
- Nonmember Price
- $269.00
- Government Price
- $269.00
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**PRE-SALE! Full title will be released on 6/16/2025.**
Volume 9 of the Environmental Monitoring series provides insight on methodologies for establishing an environmental monitoring program. There are a total of 19 chapters authored by leading experts in this area. This latest volume in this series includes useful and important topics such as requirements for incubation conditions, material transfer risks, airflow visualization studies, new insights on contamination control, and information on the various requirements for compounding pharmacies. There is guidance on how to conduct a risk assessment. There are several chapters on aerobiology, use of new technologies for air monitoring, case studies, a mold investigation plan, and concerns for dust, humidity and cleanrooms. You will find comprehensive information on molds, including a glossary of mold, prevention methods, and medical concerns with molds. A new environmental monitoring system is also introduced.
Table of Contents
1. Introduction
by
Jeanne Moldenhauer
2. Design of an Environmental Monitoring Program
by
Marsha Steed
3. Environmental Monitoring in Compounding
Pharmacies
by Susannah Davis
4. Incubation conditions and the Need for Validation
of Methods
by Jeanne Moldenhauer
5. Material transfer risk
by Tim Sandle
6. Airflow visualization studies to support the
placement of environmental monitoring samples
by Tim Sandle
7. Best Practices in Maintaining Contamination
Control
by Jim Polarine, David Shields, Matt Hofacre, Aaron Mertens,
Bruno Aze
8. A Contamination Control Investigation and its
Impact on Environmental Monitoring
by Victoria Galliani
9. Conducting an Environmental Monitoring Risk
Assessment
by Vanessa Vasadi Figueroa
10. Aerobiology
by Tony Cundell
11. Use of the BAMS for viable air monitoring
by
Christine Troutman
12. A User Case Study with the BAMS
by
Aldrin Or
13. Mold Investigation Case Study
by Crystal Booth
14. Dust, Humidity and Cleanrooms
by Tim Sandle
15. Clinical Concerns with Mold
by Michael Mansour
and Sebastian Jusuf
16. Development of a Wind Tunnel for Laboratory Use to
Sample Viable Air
by Eric Sze
17. Mold and Yeast Prevention Methods
by Brian
Hubka
18. An Automated Environmental Monitoring System
by
Jim Radigan
19. Mold Glossary
by Jeanne Moldenhauer
About the Authors
Jeanne Moldenhauer, Excellent Pharma Consulting, has over 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.